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Biotech / Medical : INHL - Inhale Therapeutics - Pulmonary Insulin! -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (206)	6/14/2003 9:08:30 PM
From: tuck	Read Replies (1) \| Respond to of 225

From ADA meeting: >>Efficacy and Safety of Inhaled Insulin (Exubera[reg]) Compared with Rosiglitazone in Type 2 Diabetes Patients Not Optimally Controlled on Diet and Exercise: Results of a 3-Month, Randomized, Comparative Trial Abstract Information Presented during: Glucose Monitoring and Insulin Delivery - 06/15/2003 (08:00 - 10:00 AM) Abstract Number: 162-OR Authors: RALPH A. DEFRONZO, FOR THE EXUBERA[reg] PHASE III STUDY GROUP Institution: San Antonio, TX Results: This study investigates whether pre-meal, rapid-acting, dry powder inhaled insulin (Exubera[reg]: INH) can provide acceptable glycemic control to significantly more subjects than rosiglitazone in type 2 diabetes patients not optimally controlled on diet and exercise. In this Phase III, multicenter study, patients (ages 35[ndash]80) were randomized to receive 3 months[rsquo] treatment with either INH prior to meals (n=76), or rosiglitazone 4 mg BID (ROS; n=69), both in conjunction with a diet/exercise regimen. INH was delivered as 1[ndash]2 inhalations of 1 or 3 mg. The INH and ROS groups had similar baseline HbA1c values (mean 9.5% vs 9.4%, respectively). The primary efficacy endpoint was the percentage of subjects attaining HbA1c <8.0% at study end; significantly more patients achieved this in the INH group (82.7%) compared with the ROS group (58.2%) (adjusted odds ratio: 7.14; 95% CI [2.48, 20.58]). Further improvement in glycemic control (HbA1c <7%) was achieved by 44.0% and 17.9%, respectively (adjusted odds ratio: 4.43; 95% CI [1.94, 10.12]). Absolute HbA1c decrease was significantly greater in the INH (-2.3%) vs the ROS (-1.4%) group (adjusted difference: -0.98%; 95% CI [-1.23, -0.55]). These metabolic improvements were accompanied by changes in body weight (1.9 kg for INH vs 0.8 kg for ROS [NS]). The rate of overall hypoglycemia (events/subject-month) was higher in the INH group compared with the ROS group (0.7 vs 0.05; risk ratio: 14.72; 95% CI [7.51, 28.83], but no severe hypoglycemic events were reported. INH-treated patients developed increased insulin antibody serum binding compared with ROS-treated patients, but without attributable clinical manifestations. Changes in pulmonary function were small and comparable between groups. Overall, no serious adverse events were reported throughout the study. In conclusion, this study suggests that inhaled insulin (Exubera[reg]) may be a valuable therapy for subjects with type 2 diabetes who do not achieve adequate glycemic control on diet and exercise alone.<< Cheers, Tuck